New Drug Approvals

New drug approvals - November 2024

15 January 2025

Audiences

Healthcare professional

Industry member

Product-type

Therapeutic Products

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Please click here (opens in new tab) for a list of summary reports of benefit-risk assessments.

For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

Drug caption

Product Name	AQUIPTA TABLET 10MG, AQUIPTA TABLET 60MG
Active Ingredient (Strength)	Atogepant monohydrate eqv Atogepant(10.0mg), Atogepant monohydrate eqv Atogepant(60.0mg)
Application type	NDA-1: New chemical entity
Product Registrant	ABBVIE PTE. LTD.
Date of Approval	29/11/2024
Registration No.	SIN17145P, SIN17146P
Indications: AQUIPTA™ is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Drug caption

Product Name	ARTESUNATE AMIVAS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 110MG/VIAL
Active Ingredient (Strength)	Artesunate(110mg/vial)
Application type	NDA-1: New chemical entity
Product Registrant	ACX HEALTH PTE. LTD.
Date of Approval	11/11/2024
Registration No.	SIN17135P
Indications: Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children (see sections 4.2 and 5.1). Consideration should be given to official guidance on the appropriate use of antimalarial agents.

Drug caption

Product Name	BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ 0.5 ML, BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ 1.0 ML
Active Ingredient (Strength)	Nirsevimab(50 mg/ 0.5 mL), Nirsevimab(100 mg / 1.0 mL),
Application type	NDA-1: New biological entity NDA-3: Subsequent strength
Product Registrant	SANOFI-AVENTIS SINGAPORE PTE. LTD.
Date of Approval	13/11/2024
Registration No.	SIN17137P, SIN17138P
Indications: Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season. Beyfortus should be used in accordance with official recommendations.

Drug caption

Product Name	OMJJARA FILM-COATED TABLET 100 MG, OMJJARA FILM-COATED TABLET 150 MG, OMJJARA FILM-COATED TABLET 200 MG
Active Ingredient (Strength)	Momelotinib Dihydrochloride Monohydrate eqv Momelotinib(100 mg), Momelotinib Dihydrochloride Monohydrate eqv Momelotinib(150 mg), Momelotinib Dihydrochloride Monohydrate eqv Momelotinib(200 mg)
Application type	NDA-1: New chemical entity
Product Registrant	GLAXOSMITHKLINE PTE LTD
Date of Approval	01/11/2024
Registration No.	SIN17131P, SIN17132P, SIN17133P
Indications: Omjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Drug caption

Product Name	TALVEY SOLUTION FOR INJECTION 3MG/1.5ML, TALVEY SOLUTION FOR INJECTION 40MG/ML
Active Ingredient (Strength)	Talquetamab(3mg/1.5mL), Talquetamab(40mg/mL)
Application type	NDA-1: New biological entity NDA-3: Subsequent strength
Product Registrant	JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Date of Approval	15/11/2024
Registration No.	SIN17141P, SIN17142P
Indications: TALVEY®, as monotherapy, is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. *Evaluated as part of Project Orbis